510(k) Report

510(k) · Cleared

Cleared

Trio Monitor

K041907510(k) AbbreviatedCleared Jul 23, 20048-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Datascope Corp. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Jul 23, 2004 as substantially equivalent to K032338 (Datascope Corp., 2004) and 1 other predicate after an 8-day review. Its family tree reaches back 4 generations to 1994.

Decided
Jul 23, 2004
Review
8 days
Class
Class II
Product code
MWI
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K933143 (1994). 25 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1996: 3 other ancestors1995: 3 other ancestors1994: 3 other ancestors1993: 1 other ancestor1991: 2 other ancestors1990: 2 other ancestors1984: 1 other ancestor1989: 1 other ancestorK933143 · Model Eli 300 Electrocardiograph · Mortara Instrument, Inc. · 1994K962970 · Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option · Spacelabs Medical, Inc. · 1997K972502 · Spacelabs Medical Integrated Multiparameter Module 90496 · Spacelabs Medical, Inc. · 1998 · recalledK993531 · Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX · Datascope Corp. · 2000 · recalled198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 9 other ancestors4 generations back: 5 other ancestors K993531 · Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX · Datascope Corp. · 2000 · recalledK972502 · Spacelabs Medical Integrated Multiparameter Module 90496 · Spacelabs Medical, Inc. · 1998 · recalledK962970 · Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option · Spacelabs Medical, Inc. · 1997K933143 · Model Eli 300 Electrocardiograph · Mortara Instrument, Inc. · 19940
  1. Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
  2. 3 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
  3. 2 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
  4. 1 generation backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
  5. This deviceK041907 Trio MonitorDatascope Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K933143Model Eli 300 ElectrocardiographMortara Instrument, Inc.1994—
−3K962970Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc.1997—
−2K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc.19983
−1K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp.20001
0 (this device)K041907Trio MonitorDatascope Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198910
199020
199120
199310
199430
199530
199630
199720
199810
199910
200410
FIG. 1 — Lineage of K041907, 1994–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MWI device

  1. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K032338Trio Monitor Model 0998-00-0600
Summary page 1
…870.2340 Electrocardiograph 21 CFR 870.2700 Oximeter 21 CFR 880.2910 Clinical electronic thermometers Predicate Device: Datascope Trio Monitor, 510(k) K032338 (FDA determination of substantial equivalence, February 11, 2004) Datascope Passport 2,…
Datascope Corp.20042
*K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX
Summary page 1
…ope Trio Monitor, 510(k) K032338 (FDA determination of substantial equivalence, February 11, 2004) Datascope Passport 2, 510(k) K993531 (FDA determination of substantial equivalence, January 13, 2000) Device Description: Mindray Bio-Medical C…
Datascope Corp.20001

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • 6 of the 25 ancestors have a recall of any class.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

What is it indicated for?

The Trio TM monitor is intended for use in healthcare settings under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), respiration and temperature as summarized in the…

Read the full statement (107 words)

The Trio TM monitor is intended for use in healthcare settings under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.

The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor

Indications for use as stated in the FDA summary.

More from Datascope Corp.

149 FDA decisions under this applicant name. See the company

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Recent decisions in MWI

The MWI category page

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https://510kreport.com/device/K041907 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041907: Trio Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041907

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026